# K053022: Synthes (Usa) Chronos-Beta-TCP

- Pathway: 510(k) (Traditional)
- Applicant: Synthes (Usa)
- Decided: Jan 23, 2006 after 89 days
- Product code: LYC (Bone Grafting Material, Synthetic)
- Device class: 2
- Regulation: 21 CFR 872.3930
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Interpore IP 200 Coralline Hydroxyapatite Granules and Blocks: named in the summary without a submission number
- (no number) chronOS, Craniofacial Applications, GXP: named in the summary without a submission number

## Most influential descendants
- K101426: Ceros TCP Granules (2010), 0 descendants of its own
- K092087: Medtronic Dental TCP (2009), 0 descendants of its own
- K070784: Inion Biorestore (2007), 0 descendants of its own

## Indications for use
Synthes chronOS is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region. Specifically, for the augmentation of deficient maxillary and mandibular alveolar ridges and the treatment of oral, maxillofacial and dental intraosseous defects including: ridge augmentation; sinus lifts; craniofacial augmentation; filling of defects of endodontic origin; filling of cystic defects; filling of extraction sites; filling of lesions of periodontal origin; repair of traumatic defects of the alveolar ridge; filling resection defects in bone tumors, cysts or other osseous defects; and substitute for autogenous or allogenic bone grafts. Synthes chronOS is intended to be gently packed or placed into the surgical site and may be combined with autogenous blood, bone marrow or saline. chronOS resorbs and is replaced with bone during the healing process.

Source page: https://510kreport.com/device/K053022
Methodology: https://510kreport.com/methodology